Psychiatry Study: Parkinson Disease

NCT02893449 | Completed DMC

• 1 other identifier: PSY PARKINSON
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief Summary

Main objective: To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation. Secondary objectives: To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.

Conditions

Parkinson's Disease

Keywords

Parkinson; SAS-SR; Social adaptation; Patients suffering from Parkinson's disease

Outcome Measures

Primary Outcomes (2)

• Global score of the SAS SR (social adjustment scale self report) scale

  3 months (after surgery)

• Global score of the SAS SR (social adjustment scale self report) scale

  6 months (after surgery)

Secondary Outcomes (20)

• Quality of life

  3 months

• Quality of life

  3 months

• Quality of life

  6 months

• Quality of life

  6 months

• Anxiety

  3 months

Study Arms (3)

SICRPPD group

OTHER

(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation

Behavioral: Social adaptation; Procedure: Deep brain stimulation

ICM group: Intensive Care Management

OTHER

Group of patients profiting from a preoperative non structured support

Behavioral: Intensive care management; Procedure: Deep brain stimulation

CG group: Control Group

OTHER

No supplementary support

Procedure: Deep brain stimulation

Interventions

Social adaptation BEHAVIORAL

Questionnaire to fill-in. The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.

SICRPPD group

Intensive care management BEHAVIORAL

In this group, the structured program of the SICRPPD group will be replaced by 3 unstructured psychiatric interviews during which patients will be assessed for their perception of the disease and the upcoming surgery. This group will allow to control for the intrinsic effect of the preoperative management independently of the remediation itself.

ICM group: Intensive Care Management

Deep brain stimulation PROCEDURE

CG group: Control Group; ICM group: Intensive Care Management; SICRPPD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women suffering from idiopathic Parkinson's disease for which the indication of treatment by deep cerebral stimulation is retained
• Obtained informed consent

You may not qualify if:

• Absence of social security
• Patient unable to be compliant
• Major patient under guardianship

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (3)

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Nancy

Nancy, 54035, France

Location

CHRU Strasbourg

Strasbourg, 67426, France

Location

Related Publications (1)

• Meyer M, Colnat-Coulbois S, Frismand S, Vidailhet P, Llorca PM, Schwan R, Spitz E. Illness perceptions in pre-operative Parkinson's disease patients. J Neural Transm (Vienna). 2023 May;130(5):647-654. doi: 10.1007/s00702-023-02629-2. Epub 2023 Apr 6.

  PMID: 37022502 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Social Adjustment

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Raymund Schwan, Prof.

  Nancy's Hospital

  PRINCIPAL INVESTIGATOR

• Gérard Barroche, Prof.

  CHU of Nancy - Central Hospital - Bd Marechal de Lattre de Tassigny - 54000 Nancy

  PRINCIPAL INVESTIGATOR

• Marie-Christine Tranchant, Prof.

  CHU of Strasbourg - 67000 Strasbourg

  PRINCIPAL INVESTIGATOR

• Franck Durif, Prof

  CHU Clermont-Ferrand - 63000 Clermont Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: September 8, 2016
• Study Start: April 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

FR (3)